PT  - JOURNAL ARTICLE
AU  - Brittain, Harry G.
AU  - Lafferty, Linda
AU  - Bousserski, Petranna
AU  - Diegnan, Glenn
AU  - Lessor, Ralph
AU  - Small, Camille
AU  - Pejaver, Satish
TI  - Stability of Revex<sup>™</sup>, Nalmefene Hydrochloride Injection
DP  - 1996 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 35--39
VI  - 50
IP  - 1
4099  - http://journal.pda.org/content/50/1/35.short
4100  - http://journal.pda.org/content/50/1/35.full
SO  - PDA J Pharm Sci Technol1996 Jan 01; 50
AB  - The stability of Revex™, nalmefene hydrochloride injection, has been studied at several temperatures for periods up to 36 months. The data were obtained using a HPLC method for the potency determination, and for the level of the sole degradation product (2,2′-bisnalmefene). These methods were found to be characterized by excellent precision, linearity, and accuracy over the analyte concentration ranges established. The stability data were found to be interpretable using first-order kinetics, and essentially comparable rate constants were calculated for both the potency loss and the formation of 2,2′ -bisnalmefene. Applying the Arrhenius equation to these data, a rate constant of 0.000441 month–1 was deduced for the reactions taking place at 25°C. This low value is consistent with the excellent stability exhibited by the product, and amply justifies its shelf life.